Treatment of tissue in sphincters, sinuses, and orifices

ABSTRACT

The invention comprises a method and apparatus for treatment of a body part. More particularly, a method and apparatus for heat treatment of tissue using a catheter inserted into a body part is described along with means for positioning the catheter and means for positioning a set of electrodes relative to a tissue sample for treatment. Still more particularly, radio frequency energy at about 400 to 500 kilohertz is used to provide heat for the tissue treatment.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.12/648,249 filed Dec. 28, 2009, which is a division of U.S. patentapplication Ser. No. 11/207,677, filed Aug. 18, 2005, which is acontinuation of U.S. patent application Ser. No. 09/356,110 filed Jul.16, 1999, now U.S. Pat. No. 7,022,105, which is a continuation-in-partof U.S. patent application Ser. No. 08/717,612 filed Sep. 20, 1996, nowU.S. Pat. No. 6,077,257, all of which are included by reference hereinin their entireties.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to treatment of tissue, particularly in thesphincters, esophagus, sinuses and other internal body orifices andstructures. Such treatment can be performed using ablation, coating,expansion, plumping, shaping, shrinking, or related techniques.

2. Related Art

Human beings are subject to a number of disorders in the sphincters,sinuses, esophagus and other internal orifices. Disorders in the rectumand colon include hemorrhoids (external and internal), fecalincontinence, prolapsed rectal muscles, rectal muscle spasms, analfissures, polyps, diverticulosus, diverticulitus, and pilonital cysts.Other internal disorders in nearby regions of the male body includeprostate cancer, blockage of the urethra and incontinence. Otherinternal disorders in nearby regions of the female body includeincontinence, vaginal bleeding, vaginal cysts, vaginal fibroids,prolapsed uterus, and related tumors or cancerous tissue. Disorders ofthe pharynx include tumors and polyps in the hypopharynx, oropharynx andnasopharynx. Disorders in adjacent structures include Barrett'sesophagus, laryngeal tumors and laryngeal polyps.

Known methods for the treatment of these disorders include surgery,pharmaceutical remedies, chemotherapeutic regimens, radiation,photodynamic therapy and lifestyle modification. These methods onlyoccasionally achieve the goal of successful treatment of disorders inorifices, sphincters, esophagus and sinuses. Moreover, these methodssuffer from several drawbacks.

Drawbacks to surgical treatment include its highly invasive nature,associated risks, possible iatrogenic effects, and high cost. Drawbacksto pharmaceutical and chemotherapeutic treatments include their relativeineffectiveness (particularly in the oral cavity and adjacentrespiratory structures) and associated side effects. Moreover, theseapproaches are contraindicated for many patients. Drawbacks to lifestylemodification include relatively poor patient compliance and relativeineffectiveness. Drawbacks to photodynamic therapy include its frequentunavailability and limited applicability. Drawbacks to radiation includeside effects such as exhaustion, radiation burns, chronic dry mouth andpermanent distortion of the taste buds. Accordingly, it would beadvantageous to provide techniques for treatment of these disorders thatare not subject to these known drawbacks.

The use of radio frequency (RF) to ablate tissue in the body (such asheart muscle) is known in the art of cardiac treatment. However, knownsystems using RF energy are sill subject to several drawbacks. One knownproblem is that it can be difficult to block the flow of bodily fluidsand gases into an area of the body where tissue ablation is takingplace. Bodily fluids can dissipate and detrimentally absorb the energyto be applied to the tissue to be ablated. Dissipation of bodily fluidsdetracts from the goal of successful tissue ablation and etching.

A second known problem in the art involves directing and positioning theelectrodes in the body cavity or orifice. Difficulties in accuratelypositioning the electrodes in the target orifice detract from treatment.Frequently, unhealthy tissue can remain unablated while healthy tissueis removed. Difficulties in directing and positioning the electrodes areparticularly problematic because one of the goals of treatment is tominimize collateral damage to healthy tissue and to completely ablatediseased tissue.

A third known problem in the art involves difficulty in the simultaneoususe of complimentary technology. Known systems do not provide foroptimal, simultaneous use of auxiliary tools for visualization, feedbacktechnology and drug administration.

Accordingly, it would be advantageous to provide improved techniques fortreatment of disorders in the esophagus, sphincters, sinuses and otherinternal body orifices. For example, it would be advantageous to providedevices bearing different arrays of curvilinear electrodes that can beretracted or extended into the target tissue that can also supportapparatus for drug administration and tissue visualization. Such deviceswould allow medical personnel to (1) visualize the tissue to be ablatedor etched, (2) seal off the area from fluids and gases that woulddisturb the area to be ablated (3) ablate all diseased tissue whilesparing healthy tissue and (4) provide for the localized administrationof drugs to numb the area and treat the disorder. These advantages areachieved in an embodiment of the invention in which medical personneluse a catheter bearing multiple controls for visualization and drugadministration, balloon-like air sacs for sealing the area and multiplearrays of curvilinear electrodes that can be extended and retracted asneeded.

SUMMARY

The invention provides a method and system for treatment of bodystructures or tissue. The particular treatment can include one or moreof, or some combination of ablation, coating, expansion, plumping,shaping, shrinking, or related techniques. The particular bodystructures or tissue can include one or more of, or some combination ofregions, including a sphincter, sinus or orifice such as the rectum,colon, esophagus, vagina, penis, larynx or pharynx.

In one aspect of the invention, an environment proximate to orsurrounding the targeted treatment region can be isolated or controlledby blocking the flow of gases or liquids using an inflatable balloonpositioned immediately adjacent to the tissue that is to be ablated. Theinflatable balloon can also serve to anchor the catheter in place andprevent the catheter from being expelled from the body. The inflatableballoon can also insure that locally administered drugs remain in thearea where most needed.

In a second aspect of the invention, positive pressure is used toinflate the balloon. Inflation of the balloon triggers the extension ofat least one curvilinear electrode into the targeted tissue. Negativepressure deflates the air sac and helps retract the curvilinearelectrodes so as to allow the catheter to be removed from the bodywithout damaging adjacent body structures. Alternately, the electrode(s)can be extended or retracted from the tissue, independently from the actof inflation or deflation of the balloon.

In a third aspect of the invention, the electrodes are coupled tosensors that measure properties of the target region, such astemperature and impedance. Measurement of these properties permits theuse of feedback technique to control delivery of the RF energy andadministration of fluids for cooling and hydrating the affected tissues.The electrodes can also be coupled to radio opaque markers to aid influoroscopic positioning.

In a fourth aspect of the invention, the catheter includes an opticalpath that can be coupled to external viewing apparatus. In this way, theposition of the electrodes in the body can be determined using fiberoptic techniques. The external viewing apparatus can also be coupled toan ultrasound probe included in the catheter.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a block diagram of a system for ablating tissue using acatheter and electrode assembly according to the invention;

FIG. 2 is a process flow diagram of a method for treatment for Barrett'sesophagus according to the invention;

FIG. 3 is a process flow diagram of a method for treatment of fecalincontinence according to the invention;

FIG. 4 is a process flow diagram of a method for treatment of femaleurinary incontinence according to the invention;

FIG. 5 is a process flow diagram of a method for treatment of maleurinary incontinence according to the invention;

FIG. 6 is a process flow diagram of a method for treatment of ahemorrhoid or pilonital cyst according to the invention; and

FIG. 7 is a process flow diagram of a method for treatment of an analfissure according to the invention;

FIG. 8 shows an alternate embodiment of the apparatus of FIG. 1according to the invention; and

FIG. 9 shows a balloon having micropores according to the invention.

DETAILED DESCRIPTION System Elements

FIG. 1 is a block diagram of a system for ablating tissue associatedwith the rectal sphincter, esophagus, urethra and other internal bodystructures using a catheter and electrode assembly.

A catheter and electrode assembly 100 for treating tissue includes acatheter 110, an expandable cage structure 120 and a control anddelivery linkage 130.

The catheter 110 includes a distal segment 111 and a proximal segment112. The distal segment includes a tapered tip 113 for easy insertioninto an orifice. The tapered tip 113 may be either flexible or rigiddepending upon the orifice into which the catheter 110 is to beinserted. The overall length of the shaft of the catheter 110 (includingthe expandable cage structure 120) from the tapered tip 113 to thejunction where the catheter 110 is coupled to the control and deliverylinkage 120 is about 65 centimeters. The diameter of the catheter 110 isabout 0.4 centimeters. In an alternative embodiment, the length anddiameter of the shaft of the catheter 110 may vary substantiallydepending upon the application.

The catheter 110 includes an expandable cage structure 120. The cagestructure 120 includes a set of struts 121, a set of curvilinearelectrodes 122 and an inflatable balloon 123.

One end of each one of the struts 121 is coupled to the distal segment111 of the catheter 110; the opposite end of each one of the set ofstruts 121 is coupled to the proximal segment 112 of the catheter. Takentogether, the distal segment 111, the cage structure 120 and theproximal segment 112 are linearly contiguous and form one continuousunit. The inflatable balloon 123 is surrounded by the set of struts 121.

The set of curvilinear electrodes 122 is embedded in the set of struts121. The electrodes 123 each include a metallic tube 124 defining ahollow lumen 125, shaped similarly to a curvilinear needle and a sensor126. In addition to ablating tissue by delivering RF energy, theelectrodes 113 are disposed to deliver at least one flowable substanceto the area of the body where ablation is to take place. In a preferredembodiment, the flowable substance includes saline with a concentrationof less than about 10% NaCl, which aids in hydration of body structures.However, in alternative embodiments, the deliverable flowable liquidsincludes other substances, including anesthetic drugs, anti-inflammatoryagents, chemotherapeutic agents, systemic or topical antibodies,collagen and radioactive substances, such as labeled tracers.

Exact positioning of the electrodes 122 is achieved by inflating theballoon 123. Inflation of the balloon 123 causes expansion of theexpandable cage structure 120, allowing one or more of the set ofelectrodes 122 to be extended directly into the targeted tissue.

The assembly 110 is operated by manipulating the control and deliverylinkage 130. The control and delivery linkage 130 includes a port 131,two female couplings 132 and 133, a mechanical switch 135 and a hand set136.

The port 131 can be coupled to both a RF source and a visualizationapparatus, such as fiber optic devices or fluoroscopy equipment, toallow internal viewing of the orifice. The two female couplings 132 and133 can be coupled to a syringe or other device to which positivepressure can be applied to inflate the balloon 123. In a preferredembodiment, one or more of the female couplings 132, 133 and 134 canalso be coupled to drug administration apparatus. Manipulation of themechanical switch 135 causes the extension of the electrodes 122. Thefemale couplings 132, 133 and 134, mechanical switch 135 and port 131are all located immediately adjacent to the hand set 136 to allow easyoperation.

First Method of Operation

FIG. 2 is a process flow diagram of a method for treatment of Barrett'sesophagus.

A method 200 is performed using a catheter and electrode assembly 100.

In a step 201, the tapered tip 113 of the catheter 110 is inserted intothe oral cavity. Due to the potential for inducing pain or a gag reflex,the oral cavity is preferably pretreated with lidocaine spray or othertopical anesthetic before insertion; depending upon the circumstances, amuscle relaxant may be indicated. In an alternative embodiment, thetapered tip 113 of the catheter 110 is inserted into a surgicallycreated stoma.

The preferred size of the catheter 110 will be responsive to the orificethrough which the catheter is inserted. The choice of pharmaceuticalagents to be infused prior to or during treatment will be responsive tojudgments by medical personnel, and may include lubricants, anesthetics,antispasmodics, anti-inflammatories, antibiotics or other agents.

In a step 202, the catheter 110 is threaded through the throat into theesophagus. Precautions are preferably taken to ensure that the catheter110 is not threaded through the trachea into the lungs.

In a step 203, the catheter 110 is positioned near the Barrett'sesophagus. In the preferred embodiment, viewing apparatus coupled to theport 131 may be used to examine the region and determine which specifictissues are targeted for ablation. Healthy tissue composed of whitesquamous cells is distinguished from unhealthy pink columnar cellsindicative of Barrett's esophagus.

In a step 204, a syringe is connected to the female coupling 132, 133 or134.

In a step 205, the syringe is used to exert positive pressure andinflate the balloon 123 with a flowable substance, such as air orliquid. Inflation of the balloon 123 serves several purposes. Inaddition to positioning the electrode 122, the balloon 123 also helpsanchor the catheter 110 and prevents gas or liquids arising in thestomach from contaminating the region.

In a step 206, inflating of the balloon 123 causes expansion of the setof struts 121. Any corrections in the positioning of the catheter 110are made at this time, using the visual apparatus coupled through theport 131.

In a step 207, one or more electrodes 122 are selected for extensioninto the columnar cells targeted for treatment. The particular treatmentcan include one or more of, or some combination of, ablation, coating,expansion, plumping, shaping, shrinking, or related techniques. Themechanical switch 134 is used to extend at least one electrode 122 intothe targeted columnar cells.

In a step 208, RF energy is provided to the electrodes so as to ablatethe targeted columnar cells. In a preferred embodiment, the RF energyhas a frequency between 435 and 485 kilohertz. The tissue immediatelynear the electrodes receives the RF energy. The strength and duration oftime the energy is applied are responsive to judgments by medicalpersonnel. In alternative embodiments, the electrodes may deliver otherforms of energy, such as heat, microwaves, infrared or visible laserenergy. In other alternative embodiments, the electrodes are controlledby a feedback technique using at least one sensor 126, such as animpedance or temperature sensor.

To perform ablation, the tissue is heated for a short period of timeuntil ablation occurs. Application of RF energy causes cell death bydehydration or denaturation of cellular proteins.

To perform expansion, plumping, or shaping, the tissue is suffused witha flowable substance, such as a gas or liquid, a collagen, or anothersubstance that can be absorbed by the body structure or tissue. Theflowable substance can be exuded from the catheter, either using aseparate flow line, or using the electrodes themselves. In a preferredembodiment, the tissue is heated for a short time, and thereaftercooled, so as to cause the flowable substance to crosslink or otherwisetransform into a bulking, plumping, or shaping agent.

To perform coating, the flowable substance can be exuded so as to adhereto (or be adsorbed by) an epithelial layer of cells. In a preferredembodiment, the tissue is heated for a short time, and thereaftercooled, so as to cause the flowable substance to crosslink or otherwisetransform into a solid mass coating or covering the epithelial layer.

To perform shrinking, the tissue is suffused with the flowablesubstance, with the flowable substance being selected so as to act as areceiving antenna or dielectric for the RF energy. RF energy is applied,which is differentially absorbed by the flowable substance; this causesthe flowable substance to heat and to shrink the tissue is suffused,either by cell death, dehydration, or denaturation of cellular proteins.

In a step 209, flowable substances are provided through the holes in theelectrodes 122, the micropores of the balloon 123 or from the struts121, if needed to immediately cool down the region and preventcollateral thermal damage. The nature, temperature and amount of theflowable substance are responsive to judgments by medical personnel.

In a step 210, the electrodes 122 are retracted back into the set ofstruts 121.

In a step 211, the balloon is deflated by negative pressure on thesyringe. Deflation of the balloon 123 causes the expandable cagestructure 120 to collapse.

In a step 212, the catheter 110 is withdrawn from the oral cavity. In analternative embodiment, the catheter 110 is withdrawn from a stoma.

Second Method of Operation

FIG. 3 is a process flow diagram of a method for treatment of fecalincontinence.

A method 300 is performed using a catheter and electrode assembly 100.This method requires the use of four to eight electrodes and a blunttapered tip 113.

In a step 301, an enema is performed to clear the region of fecalmatter. The rectum and surrounding area are washed with a cleansingagent, such as benzalonium chloride. A topical anesthetic may be appliedto prevent pain associated with insertion; depending upon thecircumstances, a muscle relaxant may be indicated. The tapered tip 113of the catheter 110 is inserted into the anus.

The preferred size of the catheter 110 will be responsive to the orificethrough which the catheter is inserted. The choice of pharmaceuticalagents to be infused prior to or during treatment will be responsive tojudgments by medical personnel, and may include lubricants, anesthetics,antispasmodics, anti-inflammatories, antibiotics or other agents.

In a step 302, the catheter 110 is threaded into the anus so that theelectrodes 122 are positioned neat the dentate line.

In a step 303, the catheter 110 is positioned neat the area to betreated. In the preferred embodiment, viewing apparatus, such as ananoscope coupled to port 131 may be used to examine the region anddetermine which specific tissues are targeted for ablation. In analternative embodiment, the area can be accessed using a colorectalultrasound probe. It is important to distinguish between the voluntaryand involuntary sphincter because fecal incontinence is frequentlycauses by defects in the involuntary sphincter. One of the goals oftreatment is to avoid exacerbating the incontinence problem by injuringthe voluntary sphincter.

In a step 304, a syringe is connected to the female coupling 132, 133 or134.

In a step 305, the syringe is used to exert positive pressure andinflate the balloon 123 with air or with a liquid. Inflation of theballoon 123 serves several purposes. In addition to positioning theelectrode 122, the balloon 123 also helps anchor the catheter 110 andprevents gas, liquid or fecal matter from contaminating the region. Ifnecessary, a second balloon can be used to anchor the catheter distally.

In a step 306, inflation of the balloon 123 causes expansion of the setof struts 121. Any corrections in the positioning of the catheter 110are made at this time, using the visual apparatus coupled through theport 131.

In a step 307, four or more electrodes 122 are selected for extensioninto the involuntary sphincter. The mechanical switch 135 is used toextent the electrodes 122 into the involuntary sphincter. Thermal injuryto sensitive female structures is avoided by selecting electrodes 122 inarea other than the anterior portion of the anus. In both sexes,treatment is directed to the area one to two centimeter above and up toone centimeter below the dentate line. Highly innervated regions oftissue are avoided so as to minimize pain.

In a step 308, RF energy is provided to the electrodes until thermallesions are created in the targeted area(s). In a preferred embodiment,the RF energy has a frequency between 435 kilohertz and 485 kilohertz.The RF energy is received by the tissue immediately near the electrodes.The tissue is heated for a short period of time until ablation occurs.Application of RF energy causes cell death by dehydration anddenaturization of cellular proteins. The strength and duration of timethe energy is applied are responsive to judgments by medical personnel.

In alternative embodiments, the electrodes may deliver other forms ofenergy, such as heat, microwaves, infrared or visible laser energy. Inother alternative embodiments, the electrodes are controlled by afeedback technique using at least one sensor 126, such as an impedanceor temperature sensor.

In a step 309, flowable substance are provided through holes in theelectrodes 122, the struts 121 or the micropores of the balloon 123 ifneeded to immediately cool down the region and prevent collateralthermal damage. The nature, temperature and amount of the flowablesubstance are responsive to judgments by medical personnel.

In a step 310, the electrodes 122 are retracted back into the set ofstruts 121.

In a step 311, the balloon 123 is deflated by negative pressure on thesyringe. Deflation of the balloon 123 causes the expandable cagestructure 120 to collapse.

In a step 312, the catheter is withdrawn from the anus.

Third Method of Operation

FIG. 4 is a process flow diagram of a method for treatment for femaleurinary incontinence.

A method 400 is performed using a catheter and electrode assembly 100.

In a step 401, the area around the urethral meatus is cleansed. Thetapered tip of the catheter 110 is well lubricated and introduced intothe urethral meatus in an upward and backward direction, in much thesame way one would introduce a Foley catheter. Due to the potential forinducing pain, the outer opening of the urethra may be pretreated with atopical anesthetic before treatment. The choice of pharmaceutical agentsto be infuse prior to or during treatment will be responsive tojudgments by medical personnel and may include lubricants, anesthetics,antispasmodics, anti-inflammatories, antibiotics or other agents.

In a step 402, the catheter 110 is threaded through the urethra untilthe tapered tip 113 reaches the neck of the bladder using strict aseptictechnique.

In a step 403, viewing apparatus coupled to part 131 may be used toexamine the region and determine which area of the urethral sphincter istargeted for treatment. Ultrasound or fluoroscopy can also be used forpositioning.

In a step 404, a syringe is connected to the female coupling 132, 133 or134 included in the control and delivery linkage 130.

In a step 405, the syringe is used to exert positive pressure andinflate the balloon 123 with air or liquid. Inflation of the balloon 123serves several purposes. In addition to positioning the electrode 122,the balloon 123 also helps anchor the catheter 110. In an alternativeembodiment, a second balloon 123 is used to help position the bladderneck and seal it off.

In a step 406, vacuum can be added to conform the tissue to theelectrodes. This step is particularly advantageous for patients whosepelvic floor muscles are in poor condition. This step is optional.

In a step 407, inflation of the balloon 123 causes expansion of theexpandable cage structure 120. Expansion of the cage structure bringsthe electrodes 122 into immediate contact with the urinary sphincter.Any correction to the position of the catheter 110 is made at this time,using the visual apparatus coupled through part 131.

In a step 408, one or more electrodes 122 are selected for extensioninto tissue targeted for ablation. The mechanical switch 135 is used toextend at least one electrode 122 into the targeted tissue.

In a step 409, RF energy is provided to the electrodes to create lesionson the targeted tissue. In a preferred embodiment, the RF energy has afrequency between 435 and 485 kilohertz. The RF energy is received bythe tissue immediately near the electrodes for a period of time lessthan ten minutes. The device can be repositioned by rotation ortranslation so the RF energy is delivered to multiple sites to create apattern of lesions over several centimeters of tissue. The duration oftime and frequency of energy are responsive to judgments of medicalpersonnel. Creation of these lesions has the effect of causing theinvoluntary sphincter to shrink so that urine does not seep through. Inalternative embodiments, muscle contraction can be achieved byapplication of chemical stimulation.

In a step 410, flowable substances are provided through holes in theelectrodes 122, the struts 121 and/or micropores of the balloon 123, ifneeded, to lower the temperature of the region and prevent collateralthermal damage. The nature, temperature and amount of flowable substanceare responsive to judgments by medical personnel.

In a step 411, the electrodes 122 are retracted back into the set ofstruts 121.

In a step 412, the balloon 123 is deflated by application of negativepressure on the syringe. Deflation of the balloon 123 causes collapse ofthe expandable cage structure 120.

In a step 413, the catheter 110 is withdrawn from the urethra.

Fourth Method of Operation

FIG. 5 is a process flow diagram of a method for treatment of maleurinary incontinence.

A method 500 is performed using a catheter and electrode assembly 100.

In a step 501, the tapered tip 113 of the catheter 110 is welllubricated. The area of the glans penis around the urinary meatus iswashed with a cleansing agent such as benzalonium chloride. Due to thepotential for inducing pain, the area surrounding the urinary means maybe pretreated with a topical anesthetic before insertion; depending uponthe circumstances, a muscle relaxant may be indicated.

The preferred size of the catheter 110 will be responsive to the orificethrough which the catheter is inserted. The choice of pharmaceuticalagents to be infused prior to or during treatment will be responsive tojudgments by medical personnel, and may include lubricants, anesthetics,antispasmodics, anti-inflammatories, antibiotics or other agents.

In a step 502, the catheter 110 is introduced into the urethra along theanterior wall. The catheter is advanced 17.5-25 centimeters. Since thelength from the bladder to the end of the glans penis varies, thedistance that the catheter is advanced in responsive to the judgment ofmedical personnel.

In a step 503, the catheter 110 is positioned near the target area fortreatment. In the preferred embodiment, viewing apparatus coupled to theport 131 may be used to examine the region and determine which specifictissues are targeted for treatment.

In a step 504, a syringe is connected to the female coupling 132, 133 or134.

In a step 505, the syringe is used to exert positive pressure andinflate the balloon 123 with air or liquid. Inflation of the balloon 123serves several purposes. In addition to positioning the electrode 122,the balloon 123 also helps anchor the catheter 110. If necessary, asecond balloon 123, located distally, can also be inflated to anchor theballoon 123 in the bladder.

In a step 506, inflation of the balloon 123 causes expansion of the setof struts 121. Any corrections in the positioning of the catheter 110are made at this time, using the visual apparatus coupled through port131.

In a step 507, one or more electrodes 122 are selected for extension.The mechanical switch 135 is used to extend at least one electrode intothe targeted tissue.

In a step 508, RF energy is provided to the electrodes so as to createlesions upon targeted regions of the urethra and bladder. In a preferredembodiment, the RF energy has a frequency between 435 and 485 kilohertz.The RF energy is received by the tissue immediately near the electrodes.The device can be repositioned by rotation or translation so that RFenergy is delivered to multiple sites to create a pattern of lesionsover several centimeters of tissue. Creation of these lesions has theeffect of causing the involuntary sphincter to shrink so that urine doesnot seep through. In alternative embodiments, muscle contraction (andthe consequence shrinkage of the involuntary sphincter) can be achievedby application of chemical stimulation. In other alternativeembodiments, the electrodes are controlled by a feedback technique usingat least one sensor 126, such as an impedance or temperature sensor.

In a step 509, flowable substances are provided through the holes in theelectrodes 122, the struts 121 and/or the micropores in the balloon 123if needed to immediately cool down the region and prevent collateralthermal damage. The nature, temperature and amount of the flowablesubstance are responsive to judgments by medical personnel.

In a step 510, the electrodes 122 are retracted back into the set ofstruts 121.

In a step 511, the balloon 123 is deflated by negative pressure on thesyringe. Deflation of the balloon 123 causes the expandable cagestructure 120 to collapse.

In a step 512, the catheter 110 is withdrawn from the glans penis.

Fifth Method of Operation

FIG. 6 is a process flow diagram of a method for treatment of ahemorrhoid.

A method 600 is performed using a catheter and electrode assembly 100.

In a step 601, the tapered tip 113 of the catheter 110 is welllubricated. An enema is performed to clear the area of fecal matter. Therectum and surrounding area are washed with a cleansing agent such asbenzalonium chloride. Due to the potential for inducing pain, the areasurrounding the rectum may be presented with a topical anesthetic beforeinsertion; depending upon the circumstances, a muscle relaxant may beindicated.

The preferred size of the catheter 110 will be responsive to the orificethrough which the catheter is inserted. The choice of pharmaceuticalagents to be infused prior to or during treatment will be responsive tojudgments by medical personnel, and may include lubricants, anesthetics,antispasmodics, anti-inflammatories, antibiotics or other agents.

In a step 602, the catheter 110 is introduced into the anus and advancedalong the walls of the sphincter. Since hemorrhoids and pilonital cystsmay occur anywhere along this passage, the distance that the catheter isintroduced is responsive to the judgment of medical personnel.

In a step 603, the catheter is positioned near the internal hemorrhoid,external hemorrhoid or cyst that is targeted for ablation. In thepreferred embodiment, viewing apparatus coupled to the port 131 may beused to examine the region and determine which specific tissues aretargeted for ablation. Ultrasound or fluoroscopy may also be employed tohelp position the catheter 110.

In a step 604, a syringe is connected to the female coupling 132, 133 or134.

In a step 605, the syringe is used to exert positive pressure andinflate the balloon 123 with air or with a liquid. Inflation of theballoon 123 serves several purposes. In addition to positioning theelectrode 122, the balloon 123 also helps anchor the catheter 110, sealoff the region and prevent contamination with fecal matter.

In a step 606, inflation of the balloon 123 causes expansion of the setof struts 121. Any corrections in the positioning of the catheter 110are made at this time, using the visual apparatus coupled through port131.

In a step 607, one or more electrodes 122 are selected for extension.The mechanical switch 135 is used to extend at least one electrode 122into the targeted tissue.

In a step 608, RF energy is provided to the electrodes so as to ablatethe hemorrhoid or cyst. In a preferred embodiment, the RF energy has afrequency between 435 and 485 kilohertz. The RF energy is received bythe tissue immediately near the electrodes. The tissue is heated for ashort period of time until ablation occurs. In an alternativeembodiment, the electrodes are controlled by a feedback technique usingat least one sensor 126, such as an impedance or temperature sensor.

In a step 609, flowable substances are provided through the holes in theelectrodes 122, the struts 121 and/or the micropores of balloon 123 ifneeded to immediately cool down the region and prevent collateralthermal damage. The nature, temperature and amount of the flowablesubstance are responsive to judgments by medical personnel.

In a step 610, the electrodes 122 are retracted back into the set ofstruts 121.

In a step 611 the balloon 123 is deflated by negative pressure on thesyringe. Deflation of the balloon 123 causes the expandable cagestructure 120 to collapse.

Steps 605 through 611 are repeated as necessary until all hemorrhoids orcysts are removed.

In a step 612, the catheter 110 is withdrawn from the anus.

Sixth Method of Operation

FIG. 7 is a process flow diagram of a method for treatment of an analfissure.

A method 700 is performed using a catheter and electrode assembly 100.

In a step 701, the tapered tip 113 of the catheter 110 is welllubricated. An enema is performed to clear the region of fecal matter.The anus and rectal area are washed with a cleansing agent such asbenzalonium chloride. Due to the potential for inducing pain, the areasurrounding the anus may be pretreated with a topical anesthetic beforeinsertion; depending upon the circumstances, a muscle relaxant may beindicated.

The preferred size of the catheter 110 will be responsive to the orificethrough which the catheter is inserted. The choice of pharmaceuticalagents to be infused prior to or during treatment will be responsive tojudgments by medical personnel, and may include lubricant, anesthetics,antispasmodics, anti-inflammatories, antibiotics or other agents.

In a step 702, the catheter 110 is introduced into the anus and advancedalong the walls of the sphincter. The distance that the catheter 110 isintroduced is responsive to the judgment of medical personnel.

In a step 703, the catheter 110 is positioned near an anal fissure. Inthe preferred embodiment, viewing apparatus coupled to the port 131 maybe used to examine the region and determine which specific tissues aretargeted for ablation and where collagen should be deposited. Ultrasoundor fluoroscopic imaging can also be used to position the catheter 110.

In a step 704, a syringe is connected to the female coupling 132, 133 or134.

In a step 705, the syringe is used to exert positive pressure andinflate the balloon 123 with air or with a liquid. Inflation of theballoon 123 serves several purposes. In addition to positioning theelectrode 122, the balloon 123 also helps anchor the catheter 110. In analternative embodiment, a second balloon 123 can be inflated, ifnecessary to help anchor the catheter 110.

In a step 706, inflation of the balloon 123 causes expansion of the setof struts 121. Any corrections in the position of the catheter 110 aremade at this time, using the visual apparatus coupled through port 131.

In a step 707, one or more electrodes 122 are selected for extension.The mechanical switch 135 is used to extend at least one electrode 122into the targeted tissue.

In a step 708, collagen is deposited into the fissure.

In a step 709, RF energy is provided to the electrodes so as to hardenthe collagen for filling the fissure. In a preferred embodiment, the RFenergy has a frequency between 435 kilohertz and 485 kilohertz. The RFenergy is received by the tissue immediately near the electrodes. Thetissue is heated for a short period of time until the collagen issufficiently hardened. In an alternative embodiment, the electrodes arecontrolled by a feedback technique using at least one sensor 126, suchas an impedance or temperature sensor.

In a step 710, other flowable substances are provided through the holesin the electrodes 122, the struts 121 and/or the micropores of theballoon 123, if needed to immediately cool down the region and preventcollateral damage. The nature, temperature and amount of the flowablesubstance are responsive to judgments by medical personnel.

In a step 711, the electrodes 122 are retracted back into the set ofstruts 121.

In a step 712, the balloon 123 is deflated by negative pressure on thesyringe. Deflation of the balloon 123 causes the expandable cagestructure 120 to collapse.

In a step 713, the catheter 110 is withdrawn from the anus.

Alternative Embodiments

Although preferred embodiments are disclosed herein, many variations arepossible which remain within the concept, scope and spirit of theinvention, and these variations would become clear to those skilled inthe art after perusal of this application.

1. A method of tissue heat treatment of urinary incontinence in a woman,comprising the steps of: inserting a catheter into the womans's urethra,said catheter comprising: a set of electrodes configured to extend intothe tissue targeted targeted for heat treatment; extending theelectrodes through the urethra and into the tissue; and deliveringelectromagnetic energy to said tissue from the electrodes, wherein saidelectromagnetic energy comprises radio frequency energy.
 2. The methodof claim 1, wherein said set of electrodes comprises four to eightelectrodes.
 3. The method of claim 2, wherein said set of electrodescomprises four electrodes.
 4. The method of claim 1, wherein the step ofextending comprises operating a mechanical control integrated into saidcatheter.
 5. The method of claim 1, further comprising the step of:anchoring said catheter through inflation of a balloon attached to saidcatheter.
 6. The method of claim 5, further comprising the step of:anchoring the catheter at or near the neck of the bladder.
 7. The methodof claim 1, further comprising the step of: repositioning said catheterby rotation.
 8. The method of claim 1, further comprising the step of:repositioning said catheter by translation to deliver electromagneticenergy to multiple target regions.
 9. The method of claim 1, whereinsaid radio frequency energy comprises energy at about 400 to 500kilohertz.
 10. The method of claim 9, wherein said step of deliveringelectromagnetic energy comprises a period of less than about tenminutes.
 11. The method of claim 10, further comprising the step of:introducing said catheter through a urethra into a bladder.
 12. Themethod of claim 1, wherein said catheter comprises a tapered tip,wherein said tapered tip is at least one of flexible and rigid.
 13. Themethod of claim 1, wherein said step of delivering radio frequencyenergy comprises denaturing of cellular proteins.
 14. The method ofclaim 1, wherein said step of extending the electrodes is independentfrom a step of anchoring said catheter.
 15. The method of claim 1,wherein said set of electrodes surround a central axis.
 16. The methodof claim 15, further comprising the step of: firmly holding saidcatheter relative to said tissue sample.
 17. The method of claim 16,wherein said set of electrodes comprises a set of about four to eightelectrodes.
 18. The method of claim 1, wherein said catheter comprises ablunt tapered tip.
 19. The method of claim 1, further comprising thestep of: cooling said tissue sample.
 20. The method of claim 19, whereinsaid step of cooling comprises the step of: delivering a flowablesubstance about said tissue sample, wherein said flowable substanceprevents collateral thermal damage.
 21. The method of claim 20, whereinsaid step of delivering a flowable substance is simultaneous with saidstep of delivering electromagnetic energy.
 22. The method of claim 1,wherein the step of inserting the catheter comprises: threading saidcatheter through the woman's urethra until a tapered tip of the catheterand deflated balloon reaches the bladder using strict aseptic technique.23. The method of claim 22, further comprising the step of: anchoringsaid catheter with a balloon.
 24. The method of claim 22, furthercomprising the step of: lubricating said tapered tip prior to said stepof threading.
 25. The method of claim 22, further comprising any of thesteps of: washing an area around the urinary meatus; and pretreating anarea around at least a portion of said urinary meatus with a topicalanesthetic before insertion.